Medical device advertising management approach a
In order to do a good job in the medical office of the safe use of medical equipment, especially the development of the "Longcheng Junior High School medical office medical equipment use disinfection and storage system":
1, all types of medical equipment have a special custody, and do a good job of registering work;
2, all types of medical equipment stored in a fixed, clean, dry, ventilated Avoid strong acid, strong alkali and other corrosive substances erosion;
3, strictly in accordance with the operating regulations of all types of medical equipment operation;
4, the operation is completed, immediately cleaned, disinfected in accordance with the "Longcheng Junior High School infirmary routine disinfection system," the requirements of disinfection, ready for the next time to use;
5, long-term non-use of medical equipment and do a good job of cleaning and lubricating oil and other protective work, and appropriate Lubricating oil and other protective work, and properly stored;
6, all types of medical equipment, such as failure or damage, immediately notify the repairman or contact with the manufacturer;
7, the establishment of the medical clinic medical equipment routine inspection of the storage system, every two weeks to check, and register. Regulations on the Supervision and Administration of Medical Devices", "Hospital Infection Management Measures", "Disinfection Management Measures" and other provisions of the development of this specification.
Article 2 of the clinical use of medical devices safety management, refers to medical institutions involved in medical services, medical device product safety, personnel, systems, technical specifications, facilities, environment and other safety management.
Article III of the Ministry of Health in charge of the national safety supervision of the clinical use of medical devices, the organization of the development of safety management standards for the clinical use of medical devices, according to the principles of medical device classification and risk grading to establish the clinical use of medical devices and monitoring and evaluation system, the organization of the clinical use of medical devices to carry out the monitoring and evaluation work.
Article IV of the local health administrative departments at or above the county level is responsible for the Ministry of Health in accordance with the relevant management standards and monitoring and evaluation system requirements, to organize and carry out the work of clinical use of medical devices within the administrative region of the safety supervision.
Article 5 medical institutions should be based on the development of the norms of the clinical use of medical equipment safety management system, the establishment of a sound management system for the clinical use of medical devices.
Hospitals above the second level should be set up by the leadership of the hospital responsible for the clinical use of medical devices safety management committee, the committee consists of medical administration, clinical medicine and nursing, hospital infection management, medical device security management and other relevant personnel to guide the clinical safety management and monitoring of medical devices.
Chapter II Clinical Access and Evaluation Management
Article 6 of the medical device clinical access and evaluation management refers to the medical institutions to ensure that the entry into the clinical use of medical devices are legal, safe and effective, and the management and technical measures taken.
Article 7 medical institutions should establish medical device procurement demonstration, technical evaluation and procurement management system to ensure that the procurement of medical devices meet clinical needs.
Measures for the management of medical device advertising III
1. Purpose
To ensure that the quality of medical devices issues, and improve the credibility of our company.
2, based on
This system is based on the "Hunan Medical Device Business Enterprise Inspection and Acceptance Standards" and the Company's relevant systems developed.
3, scope
This system applies to the company engaged in the wholesale business of medical equipment departments.
4, content
4.1 should be obtained from the "Medical Device Manufacturer License" or obtain "Medical Device Operator License" of the enterprise purchased with "Medical Device Product Registration Certificate" of the goods, carefully check the ? Certificate, license? s legitimacy and validity, to prevent counterfeiting, and properly save a copy of the qualification documents stamped with the official seal of the supplier.
4.2 In the purchase of medical devices to choose a legitimate supplier, and collect the supplier's "Medical Device Manufacturer's License" (or "Medical Device Operator's License") and business license and other valid documents.
4.3 Purchased products must be legal products, collect product "Medical Device Manufacturer's License" (or "Medical Device Operator's License") and "Medical Device Product Registration Certificate" and the relevant product standards for quality certification.
4.4 Purchase of the first goods, need to be qualified by the quality department audit, signed by the manager before entering the goods.
4.5 Shall not purchase unregistered medical devices, shall not purchase can not be qualified certificate, expired, invalid or out of medical devices.
4.6 Purchase of medical devices should be supplied to the manufacturer to obtain legal bills, purchase management to have a complete purchase file, and in accordance with the provisions of the establishment of the purchase records, records of the date of purchase, supply unit, purchase quantity, product name, production unit, model specifications, production batch size, sterilization batch size, the expiration date of the product and the operator, the quality of acceptance of the staff signature and so on, the purchase records should be true and complete. To do bills, accounts, goods in line with the records are properly preserved in accordance with the provisions.
4.7 Effective date of goods purchases, in strict accordance with the ? Diligent into the quick sale, supply and demand smooth, orderly operation? The principle of preventing inventory backlogs causing unnecessary losses.
4.8 Annual quality review of purchases.
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